American Academy of Ophthalmology Meeting
American Academy of Ophthalmology Meeting
Source/Disclosures
Source:

Riemann CD. Phase 1/2a study of subretinally transplanted hESC-derived RPE cells in advanced dry-form AMD patients. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).

Disclosures: Riemann reports he is a consultant and investigator for Gyroscope Therapeutics and Lineage/BioTime.
November 18, 2020
2 min read
Save

Dry AMD eyes treated with RPE cell transplantation show positive visual results

Source/Disclosures
Source:

Riemann CD. Phase 1/2a study of subretinally transplanted hESC-derived RPE cells in advanced dry-form AMD patients. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).

Disclosures: Riemann reports he is a consultant and investigator for Gyroscope Therapeutics and Lineage/BioTime.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Patients with dry age-related macular degeneration who underwent subretinal transplantation of retinal pigment epithelial cells derived from human embryonic stem cells experienced stable or improved vision.

“OpRegen eyes appear to tolerate the transplanted cells, may have restored retinal outer layer anatomy, may have slowed geographic atrophy progression, and may have stable or improved vision while anatomic and visual consequences of the disease appear to progress in the untreated fellow eyes,” Christopher D. Riemann, MD, said at the virtual American Academy of Ophthalmology annual meeting.

Riemann presented interim results of a phase 1/2a clinical trial of OpRegen (Lineage Cell Therapeutics), subretinally transplanted RPE cells derived from human embryonic stem cells, in patients with advanced dry AMD and geographic atrophy. The primary objective was safety and tolerability of the treatment, while survival and possible effects of the treatment on retinal structure and function were also evaluated.

The trial consists of four cohorts. Cohorts 1 through 3 are fully enrolled with 12 patients, all of whom have poor vision and large geographic atrophy and underwent the transplant therapy in a traditional vitrectomy and retinotomy approach.

The fourth cohort has eight of 12 patients enrolled, all of whom have better vision and smaller geographic atrophy. Four patients underwent the transplant with a traditional procedure, and four patients underwent the cell transplantation with the Orbit subretinal delivery system (SDS, Gyroscope Therapeutics). The Orbit SDS is designed to deliver a subretinal bleb therapeutic without vitrectomy or retinotomy, Reimann said.

Overall, vision remained stable or improved in all eyes. No inflammatory response to the transplanted cells was observed.

“Safety signals notably included subretinal pigmentation in 10 of 16 vitrectomy-operated patients and two of four Orbit SDS-operated patients. This has persisted out past 4 years of follow-up in some of the early cohort patients. We think this may be a positive sign of long-term cell survival,” Reimann said.

In terms of possible efficacy signals, some eyes had a slow progressive reduction of drusen in the macular region of the transplant over time, visible on both color fundus photography and OCT.

A significant visual acuity signal may have been observed in cohort 4, as all treated eyes experienced stable or improved vision over time and contralateral eyes experienced stable or worse vision.

“Despite only eight patients having been operated, two of which with less than 2 months of follow-up, the improved visual acuity signal in treated vs. fellow eyes reached statistical significance at the 9- and 12-month follow-up time points,” Reimann said.